Parexel Blog

Parexel Blog

  • Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...

    Learn More
  • English Requirement for FDA GMP Documents

    Generally, overseas manufacturers in non-English speaking countries have their GMP documentation in the local language so that the staff working at the facility are able to read and understand the...

    Learn More
  • #ParexelWithPride - Employee contributes to the landmark ruling in Botswana

    On Tuesday, June 11, the High Court of Botswana issued a unanimous decision decriminalizing same-sex sexual conduct between consenting adults.  The Southern Africa Litigation Centre (SALC) hailed...

    Learn More
  • RIM Blog Series - Part 2: Mind the gap

    As discussed in my previous paper, RIM started about 15 years ago and is a discipline that supports Life Sciences Regulatory Processes. In 2003, capturing Regulatory information was a...

    Learn More
  • Improving the Odds of Success in Prostate Cancer Therapy Development

    Improving the Odds of Success in Prostate Cancer Therapy Development

    In recognition of Men’s Health Month, Parexel offers a deep dive into the challenges of developing therapies for prostate cancer.  Despite significant research advances, prostate cancer remains...

    Learn More
  • Thank you for Joining with Parexel to Mark International Clinical Trials Day

    Over the last few weeks Parexel has been celebrating International Clinical Trials Day, aimed at raising awareness of the impact of clinical trials and honoring the patients participating in...

    Learn More
  • Bispecific Antibody Development Program Guidance

    Earlier this month FDA released a draft guidance called “Bispecific Antibody Development Programs”.  This is a welcome addition to FDA’s set of guidance documents for biotechnology...

    Learn More
  • Learn how to adapt innovative precision medicine trials from industry experts convened by Parexel

    During an expert panel convened by Parexel and Pharma Intelligence in Santa Clara, industry leaders discussed the use and optimization of precision medicine trial strategies. ...

    Learn More
  • Tina Aswani Omprakash shares her experience of living with Crohn’s disease and participating in a clinical trial

    In her early 20s, Tina Aswani Omrakash was a busy, young professional living in New York City.  Her life was then derailed and “the rug pulled out from under her” when she began a 10-year journey...

    Learn More
  • RIM Blog Series - Part 1: It’s not a technology, it’s a discipline

    Fifteen years after coining the term Regulatory Information Management (RIM), I still see many conversations and discussions taking place about “What is RIM”.  To me, the definition has always...

    Learn More
  • Parexel Celebrates International Clinical Trials Day

    Every year, International Clinical Trials Day represents an opportunity to raise awareness of the impact of clinical trials and honor the people who help drive clinical research all over the...

    Learn More
  • T.J. Sharpe shares his experience battling melanoma and participating in clinical trials

    At the age of 25, T.J. Sharpe was diagnosed with melanoma, which was removed successfully. Years later, married and with two young kids, he learned his melanoma had returned with tumors in...

    Learn More
  • The State of Germline Gene Editing. What We Don’t Know!

    According to NIH “germline alteration involves a specific attempt to introduce genetic changes into the germ (reproductive) cells of an individual, with the aim of changing the set of genes passed...

    Learn More
  • Ask the Expert Blog Series: Cystic Fibrosis

    Ask the Expert Blog Series: Cystic Fibrosis

    Bertrand Sohier, MD, is the Global Therapeutic Area Head for Pulmonology, Critical Care, Cardiovascular and Endocrinology within Parexel’s Global Medical Services division. A board-certified...

    Learn More
  • Key Questions to Consider When Licensing Cell & Gene Therapy Products

    Manufacturers often ask if there is a checklist for CMC readiness before entering pivotal or Phase III study or if they plan to ask the agency for one of many expediated designations. Since the...

    Learn More
  • A New Day for Parexel

    Over the last 37 years, Parexel has established a rich heritage focused on the development and commercialization of innovative new therapies for patients. Our colleagues around the world are...

    Learn More
  • Unlocking Drug Development Innovation with the Right People, Processes & Culture

    In this video, Albert Siu, Corporate Vice President, Learning & Development, discusses Parexel's multi-layered approach to ensuring the strength and integrity of our global workforce.  To...

    Learn More
  • The Parexel Podcast Episode 2: Tackling Rare Diseases & Inside the FDA

    Recorded during the 2019 World Orphan Drug Congress, this episode brings together Amy McKee and Mo Heidaran who both recently joined PAREXEL from the FDA, as well as Zizi Imatorbhebhe,...

    Learn More
  • Could Netflix-Style Pricing Spark A Renaissance in Antimicrobial Research

    Could Netflix-Style Pricing Spark A Renaissance in Antimicrobial Research

    The discovery of penicillin heralded the first in a series of victories in the war against disease, providing the foundation for advances in surgery and medicine which would have been...

    Learn More
  • Ask The Expert Blog Series: Malaria

    Ask The Expert Blog Series: Malaria

    Nathalie Sohier, MD, MPH is a Senior Medical Director and Global Therapeutic Area Head for Infectious Diseases and Vaccines within PAREXEL’s Global Medical Services division. Nathalie...

    Learn More
  • loading
    Loading More...